Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis
Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis
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DOI：
10.1136/ard.2004.020875
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发表时间：
2004-12-01
影响因子：
27.4
通讯作者：
Fatenejad, S
中科院分区：
文献类型：
--
作者：
Calin, A;Dijkmans, BAC;Fatenejad, S
目的：采用双盲、随机、安慰剂对照研究，评价依那西普治疗成人强直性脊柱炎(AS)的安全性和有效性。方法：将14个欧洲地区的AS患者随机分为两组，每周2次，每次25 mg，共12周。主要疗效终点是根据强直性脊柱炎(ASAS)反应标准(ASAS 20)的多组分评估，患者报告的症状至少改善20%。次要终点包括ASAS50和ASAS70个反应，以及在ASAS的个别组成部分、巴斯强直性脊柱炎疾病活动指数(BASDAI)、急性时相反应物和脊柱活动测试上的改善分数。结果：在入选的84名患者中，45名接受依那西普治疗，39名接受安慰剂治疗。依那西普患者比安慰剂患者早在第2周就有更多的患者在ASS20水平上有反应，持续到第12周有明显的差异。显著更多的依那西普患者报告在所有时间都有50个反应，在第2、4和8周有70个反应；报告较低的综合和疲劳BASDAI评分；有较低的急性时相反应物水平；以及改善了脊柱屈曲。依那西普耐受性良好。不良反应多为轻至中度，唯一的组间差异是注射部位反应，在依那西普患者中发生率明显更高。结论：依那西普是一种耐受性好的有效治疗AS的临床症状和体征的药物。
Objective: A double blind, randomised, placebo controlled study to evaluate the safety and efficacy of etanercept to treat adult patients with ankylosing spondylitis (AS).Methods: Adult patients with AS at 14 European sites were randomly assigned to 25 mg injections of etanercept or placebo twice weekly for 12 weeks. The primary efficacy end point was an improvement of at least 20% in patient reported symptoms, based on the multicomponent Assessments in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20). Secondary end points included ASAS 50 and ASAS 70 responses and improved scores on individual components of ASAS, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), acute phase reactants, and spinal mobility tests. Safety was evaluated during scheduled visits.Results: Of 84 patients enrolled, 45 received etanercept and 39 received placebo. Significantly more etanercept patients than placebo patients responded at the ASAS 20 level as early as week 2, and sustained differences were evident up to week 12. Significantly more etanercept patients reported ASAS 50 responses at all times and ASAS 70 responses at weeks 2, 4, and 8; reported lower composite and fatigue BASDAI scores; had lower acute phase reactant levels; and had improved spinal flexion. Etanercept was well tolerated. Most adverse events were mild to moderate; the only between-group difference was injection site reactions, which occurred significantly more often in etanercept patients.Conclusions: Etanercept is a well tolerated and effective treatment for reducing clinical symptoms and signs of AS.